Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Diabetes Mellitus Clinical Trial

Official title:

Effect of Alpha-lipoic Acid on Inflammatory and Cardiac Fibrosis Markers in Diabetic Patients With Ischemic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06056687
• Other study ID #: ALA in Ischemic Cardiomyopathy
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of alpha-lipoic acid on inflammatory markers and cardiac fibrosis markers in diabetic patients with Ischemic Cardiomyopathy.

Description:

• A 3-month, prospective double blind interventional study, which will include 60 patients with type II Diabetes Mellitus with Ischemic Cardiomyopathy on optimal standard medical therapy, who will be consecutively randomized into two groups, group on ALA 600 mg once daily and the second group on placebo once daily.

• Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. A written informed consent will be obtained from patients before begining of the study.

• All patients will undergo complete physical examination at baseline and after 3 months of treatment.

• Patients will be assessed using Echocardiography before and after the study focusing on:

Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD) and both systolic and diastolic function.

-Measurements of inflammatory markers such as [C-reactive protein (CRP), Tumor necrosis factor alpha (TNFα)] and fibrosis markers such as [Transforming growth factor beta (TGFβ), Matrix metalloproteinase 2 (MMP-2)] at the beginning of the study and after 3 months of the study.

Study Outcomes: all patients will be followed up for 3 months for:

• 1ry outcomes: Change in inflammatory and fibrosis markers levels. LV Echocardiography improvements of any of basic Echo parameters.

• 2ry outcomes: Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. any side effects of the drug. Results The results of the study will be tabulated and statistical tests appropriate to the study will be conducted to evaluate significance of results.

conclusion Conclusion, and recommendations will be given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria:

• Type 2 diabetes with a history of CAD.

• LV ejection fraction (LVEF) =40%.

• Ischemic heart failure patients with NYHA grade II-IV.

Exclusion criteria:

• Type 1 diabetes.

• Severe CKD with GFR = 15 ml/min/1.73m^2.

• Severe liver disease.

• Thyroid disorders.

• Acute febrile illness.

• Autoimmune disorders or connective tissue disorders.

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetes Mellitus
• Ischemia
• Ischemic Cardiomyopathy

Intervention

Drug:
• Alpha Lipoic Acid 600 MG Oral Tablet
Alpha Lipoic Acid 600 MG Oral Tablet once daily

Other:
• Placebo Tablet
Placebo Tablet once daily

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.	Damanhur	Elbehairah

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein (CRP)	Serum Biomarker (mg/ml)	3 month
Primary	Tumor necrosis factor alpha (TNFa)]	Serum Biomarker (pg/ml)	3 Months
Primary	Transforming growth factor beta (TGFß)	fibrosis markers (ng/ml)	3 Months
Primary	Matrix metalloproteinase 2 (MMP-2)	fibrosis markers (ng/ml)	3 Months